Home NDC 0536-1108 Nicotine
Product NDC 0536-1108
11-digit product format 005361108
Labeler code 0536
Product ID 0536-1108_4db08daa-369f-52ce-4876-e03455838521
Type HUMAN OTC DRUG
Nonproprietary name Nicotine
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Rugby Laboratories
Application NDA020076
Marketing category NDA
Marketing start 2016-04-01
Substance NICOTINE
Active strength 21 mg/24h
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020076-004 HABITROL NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 N020076-005 HABITROL NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 N020076-006 HABITROL NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020076-004 HABITROL 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N020076-005 HABITROL 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N020076-006 HABITROL 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 19 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nicotine
Brand name suffix transdermal system step 1
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 21 mg/24h
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198029 Internal RxNorm lookup 198030 Internal RxNorm lookup 198031 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-1108-52 Nicotine transdermal system step 1 24 h in 1 PATCH PATCH, EXTENDED RELEASE 24 11 0536-1108-52 Nicotine transdermal system step 1 7 in 1 CARTON PATCH, EXTENDED RELEASE 7 11 0536-1108-71 Nicotine transdermal system step 1 24 h in 1 PATCH PATCH, EXTENDED RELEASE 24 11 0536-1108-71 Nicotine transdermal system step 1 28 in 1 CARTON PATCH, EXTENDED RELEASE 28 11 0536-1108-88 Nicotine transdermal system step 1 24 h in 1 PATCH PATCH, EXTENDED RELEASE 24 11 0536-1108-88 Nicotine transdermal system step 1 14 in 1 CARTON PATCH, EXTENDED RELEASE 14 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1108 NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [RUGBY LABORATORIES] 10 Current NDC, Legacy NDC, 6 package rows 20240726_ae406389-0f83-d5c8-bd2f-56075e57453a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0536-1108-52 00536110852 7 PATCH in 1 CARTON (0536-1108-52) / 24 h in 1 PATCH 7 patch 2026-03-20 No No Current 0536-1108-71 00536110871 28 PATCH in 1 CARTON (0536-1108-71) / 24 h in 1 PATCH 28 patch 2026-03-20 No No Current 0536-1108-88 00536110888 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH 14 patch 2016-04-01 0000-00-00 No No Current